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Published March 2020 Reviewed March 2021 Author:  Dr Greg Burch: Clinical Director, Tiny Medical Apps Table of Contents  1.0 Executive Summary 2.0 Background 3.0 National assessment and local assurance 4.0 Evaluation 4.1 Content evaluation and evidence base Evidence for asthma plans and self-management education reducing hospital attendances NICE Asthma Quality Standard (QS25) Sept 2018 Validated Behaviour Change Techniques 4.2 Digital Health Passport assessment against NICE standards The NICE Digital Health Technology tiers Tier 2 Evidence for the Digital Health Passport Partial Evidence for Tier 3a 4.3 NASSS Framework Evaluation Assessment overview 4.4 Clinician Evaluation 4.5 Patient Evaluation 4.6 Technical Assessment Evaluation Report Appendices Appendix 1 - Clinician co-design and feedback Appendix 2 - Patient feedback 1.0 Executive Summary Thanks to the investment from Healthy London Partnership, the Digital Health Passport has overcome all of the barriers needed to be ready to scale. Projects are already underway in Manchester and Sheffield capitalising on the work done to date. This report gives some background to the work before the pilot and focuses on the initial evaluation work. Evaluation will be continuous as we gain more data and increase user numbers. The Digital Health Passport has been designed for teenagers to take control of their health and has an initial focus on asthma self-management with Asthma UK action plans. enables remote tracking of symptoms, displaying emergency plans and accessing NHS support. has been co-designed with young people and health care professionals including school nurses, asthma nurses, GPs and consultant asthma specialists from paediatrics and adult services. addresses key recommendations in: NICE Asthma Quality Standard, BTS/SIGN clinical guideline 153, GINA 2019 and The National Review of Asthma Deaths (NRAD 2014). meets all high level NHS assurances and has been accepted into the NHS Apps Library and is assured to use NHS login. has been assessed to contain 14 Validated Behaviour Change Techniques. From the NICE Digital Evidence Standards Framework the DHP demonstrates evidence of effectiveness at Tier 2 and partial evidence for Tier 3a. TMA have evaluated the DHP Pilot using the NASSS Framework to inform both future adoption, use and commissioning.  Interviews were carried out with users of the DHP and gave overwhelmingly positive feedback. Valuable information has been obtained to influence the design and adoption of the next version. Twelve site visits to observe and evaluate use of the portal and seven follow up interviews with clinicians were conducted to ensure their requirements were met.   2.0 Background The Digital Health Passport has been designed for young people to take control of their health – creating asthma action plans, tracking symptoms and accessing NHS support. The project has been led and commissioned by the NHS Healthy London Partnership, Children & Young People’s team as part of their work to improve asthma standards in London. In the past few years young people in the UK have had worse outcomes from asthma than in most other countries in Europe, and there have been a number of preventable asthma deaths. Young people with a personalised asthma action plan are four times less likely to go to A&E - so a key feature of the app is the action plan from Asthma UK which gives instructions and advice of what to do if your asthma is getting worse. The Digital Health Passport has been co-produced with young people, school nurses, GPs and asthma specialists in east London and is now available in the NHS Apps Library by invite only as it is further refined with the first users. It is being piloted and tested at the Royal London and Barts hospitals and at Chrisp Street GP practice in Tower Hamlets. This innovative project has been recognised by NHS England and is one of only a handful of ‘Personal Health Record’ Apps to be evaluated around the country. It is now being rolled out in Greater Manchester and South Yorkshire with additional features planned to support young people with allergies, epilepsy and other long-term conditions. The main features of the Digital Health Passport are Asthma UK action plan Emergency plan Track symptoms on a visual timeline NHS health advice and Asthma management educational information Air quality levels (pollution, pollen and weather changes)   3.0 National assessment and local assurance The Digital Health Passport requires a high level of regulatory assurance.  Significant effort has gone into delivering a safe and assured platform.  NHS Apps Library Gaining acceptance to the NHS Apps Library has been time consuming, but is a huge assurance hurdle that has been overcome. The bedrock of the process is the Digital Assessment Questionnaire (DAQ) which requires passing assurance in seven domains from clinical need, evidence to information governance and security. NHS Login The developers Tiny Medical Apps were invited to be in the first wave of companies allowed to use NHS login. We have invested in attaining all of the additional assurance requirements to enable rapid integration with regional Local Health & Care Records such as One London. Clinical Safety DCB 0129, DCB 0160:  These standards provide a set of requirements suitably structured to promote and ensure the effective application of clinical risk management by those health organisations that are responsible for the deployment, use, maintenance or decommissioning of Health IT Systems within the health and care environment. ISO/IEC 27001 ISO/IEC 27001 Information Security Management system is designed to help organisations manage their information security processes in line with international best practice Our certification is externally audited by BSI and our scope specifically covers the Digital Health Passport platform. Cyber Essentials + Cyber Essentials helps us to guard against the most common cyber threats and demonstrates our commitment to cyber security. We are Cyber Essentials + certified which means we are also externally audited. SCAL The Supplier Conformance Assessment List (SCAL) is a technical document which details the consumer supplier approach to information governance, clinical safety, functional testing and SMSP-PDS requirements. As part of our compliance and conformance assessment for NHS Login we successfully completed the requirements of the SCAL. Data Security and Protection Toolkit The Data Security and Protection Toolkit is an online self-assessment tool that allows organisations to measure their performance against the National Data Guardian’s 10 data security standards. All organisations that have access to NHS patient data and systems must use this toolkit to provide assurance that they are practising good data security and that personal information is handled correctly. 4.0 Evaluation 4.1 Content evaluation and evidence base The content of the Digital Health Passport is consistent with the best evidence for reducing asthma exacerbations and reducing unplanned hospital attendances as part of a supported case management approach. The asthma plan and the educational content is provided by Asthma UK and the NHS Having a personalised asthma action plan is a NICE quality standard. Improving outcomes will come from behaviour change and patient activation. From the first pilot we are introducing behaviour change techniques that will expand, test and refine in future iterations. A Queen Mary’s University study demonstrated 14 behaviour change techniques within the Digital Health Passport app. Evidence for asthma plans and self-management education reducing hospital attendances The evidence in favour of supported self-management for asthma is overwhelming. Self-management including provision of a written asthma action plan and supported by regular medical review, almost halves the risk of hospitalisation, significantly reduces emergency department attendances and unscheduled consultations, and improves markers of asthma control and quality of life (Pinnock, Breathe 2015). The British Thoracic Society/Scottish Intercollegiate Guideline Network (BTS/SIGN) asthma guideline cites 261 randomised controlled trials reported in 22 systematic reviews in support of its grade A recommendation that “all people with asthma (and/or their parents or carers) should be offered self-management education which should include a written personalised asthma action plan and be supported by regular professional review” NICE Asthma Quality Standard (QS25) Sept 2018 NICE Quality Statement 1 “People (5 years old and over) with asthma discuss and agree a written personalised action plan.” What the quality statement means for each audience: Service providers ensure systems are in place for people with asthma to receive a written personalised action plan. Healthcare professionals ensure they give people with asthma a written personalised action plan. Commissioners ensure they commission services that give people with asthma a written personalised action plan. People with asthma receive a written plan with details of how their asthma will be managed. A written personalised action plan (such as Asthma UK's asthma action plan) should be tailored to the person with asthma, enabling them to recognise when symptoms are worse. The plan should set out actions to be taken if asthma control deteriorates and who to contact. Source guidance: NICE guideline NG80, (2017) Asthma: diagnosis, monitoring and chronic asthma management, recommendations 1.10.1 and 1.10.2 BTS/SIGN clinical guideline 153(2016) British guideline on the management of asthma, recommendation 5.2.2 GINA 2019 Global Initiative for Asthma  Ch 3, pg69 The National Review of Asthma Deaths (NRAD 2014) recommended the use of Personalised Asthma Action Plans as have multiple Coroners’ reports into avoidable deaths from asthma. Validated Behaviour Change Techniques The provision of  an agreed self-management plan and educational materials are core features of the Digital Health Passport, however in order to maximise the potential of the tool we are including validated behaviour change techniques and plan to test their effectiveness in a large randomized controlled trial in east London in the coming years. An analysis by Dr Samaresh Mazumdar and Dr Liz Edwards, under supervision of Prof Chris Griffiths and Dr Anna De Simoni of Queen Mary’s University London identified the 14 BCT’s in use in the app and recommended additional methods we could introduce based on analysis of 50 asthma apps used internationally. We jointly identified the Australian app ‘Kiss My Asthma’ as the leader in the field and worth emulating in many respects. Future versions will incorporate and evaluate further BCTs based upon the recommendations from QMUL researchers, particularly with greater ability to contribute to the care plan from patients with regard to goal setting, action planning and thus increased status within the team. Features such as medication reminders and ‘gamification’ are being introduced into the next version. From the BCT taxonomy we can demonstrate the use of the following techniques: 1.2 - Problem Solving - with the use of information provided in videos about avoiding triggers 1.4 - Action Planning - in the action plan/emergency  2.3 - Self Monitoring of behaviour - logging of peak flows 2.4 - Self monitoring of outcomes of behaviour - symptom logging 3.1 - Social support unspecified - 'my team' section 4.1 - Instruction on how to perform behaviour - video instructions on PEFR/spacer use 5.1 - Information about health consequences - outlined in videos 5.4 - Monitoring of emotional consequences - mood log 6.1 - Demonstration of behaviour - video instructions on PEFR/spacer use​ 8.1 - Behavioural Practice - videos and encouraging daily peak flows/preventer use 8.3 - Habit Formation - encouraging daily use through the timeline/ calendar homepage 9.1 - Credible Source - Asthma UK/NHS branding  11.1 - Pharmacological Support - encouraging the use of inhalers 15.3 - Focus on past success - calendar homepage showing previous good days Full taxonomy by Michie et al It contains 93 techniques to change behavior that are hierarchically clustered into 16 groups. 4.2 Digital Health Passport assessment against NICE standards The Digital Health Passport can now demonstrate evidence of effectiveness at Tier 2 and partial evidence for Tier 3a (Behaviour change techniques). The NICE Digital Health Technology tiers   Digital Health Technology (DHTs) are classified by function and stratified into evidence tiers (based on level of risk) Tier 1 DHTs with potential system benefits but no direct user benefits Tier 2 DHTs which help users to understand healthy living and illnesses but are unlikely to have measurable user outcomes.  Inform Simple monitoring Communication  Tier 3a DHTs for preventing and managing diseases. They may be used alongside treatment and will likely have measurable user benefits. Preventative behaviour change Self-manage Tier 3b DHTs with measurable user benefits, including tools used for treatment and diagnosis, as well as those influencing clinical management through active monitoring or calculation. It is possible DHTs in this tier will qualify as medical devices.  Treat Active monitoring Calculate Diagnose We aim to demonstrate complete evidence of effectiveness at Tier 3a in the next 12 months by evaluating with licensed Patient Activation Measure scores (skills, knowledge and confidence to self-manage). Higher-risk Digital Health Tools require a higher level of evidence for the Tier. Children and vulnerable groups are at higher risk. This means a higher level of evidence is required for the Digital Health Passport than if it was only for adults. Tier 2 Evidence